Philips D2cwc Transducer Probes recalled for labeling clarification
Philips Ultrasound recalls 171,322 D2cwc Transducer Probes nationwide to provide clarification labeling on device useful life. Facilities should review updated labeling for proper device management and replacement schedules.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class III medical device recall focused on labeling clarification for device useful life definition. No reported illnesses or injuries. The recall addresses a documentation/labeling issue that, while not indicating a safety defect, requires clarification for proper device management and operational guidance.
Plain-English summary
Philips Ultrasound, Inc. is recalling D2cwc Transducer Probe units distributed nationwide in the United States. The recall affects approximately 171,322 units across multiple model numbers and associated lot codes.
The recall is being issued to provide clarification and labeling to define the useful life of ultrasound transducers in the field. This labeling clarification ensures medical facilities have clear guidance on device lifespan and proper replacement timing.
Healthcare facilities and medical professionals using these transducer probes should review the updated labeling from Philips to understand the defined useful life of their devices. Facilities should follow the manufacturer's updated guidance on device maintenance schedules and replacement procedures.
The recalled product
- Product
- D2cwc Transducer Probe
- Manufacturer
- Philips Ultrasound, Inc
- Hazard
- unclear-labeling
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Model No. 989605438551
- 989605412052
- 989605400802
- UDI: (01)00884838061347(21)B1XJV9
- (01)00884838061347(21)B1XKWM
- (01)00884838061347(21)B1YLM8
- (01)00884838061347(21)B2RY5Q
- (01)00884838061347(21)B33Z0G
- (01)00884838061347(21)B33Z8X
- (01)00884838061347(21)F07Y3Y
- (01)00884838061347(21)F0DB0C
- 010088483806134721F0GCXL
- 010088483806134721F0G55C
- N/A
- (01)00884838061347(21)B1YLVZ
- (01)00884838061347(21)B2YJM2
- (01)00884838061347(21)F09VWC
- (01)00884838061347(21)F052VD
- (01)00884838061347(21)F087H0
- (01)00884838061347(21)F08LH8
Distribution
Distributed nationwide across the United States.
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